Liquid pharmaceutical products for parenteral use e.g. through injection or infusion are often stored in glass vials with a stopper or in glass ampoules. In order to gain access to the stored pharmaceutical products typically several handling steps are necessary. Furthermore, hypodermic needles are required for extracting the pharmaceutical product.
If, for example, a pharmaceutical product shall be extracted from a glass ampoule, the pharmaceutical product has first to be transferred from the ampoule head back into the ampoule body before removal of the ampoule head for opening of the glass ampoule. Then the ampoule head has to be removed from the ampoule body either by sawing off the ampoule head by applying two to three sawing strokes with an ampoule saw to a predetermined breaking point at the ampoule neck, the ampoule shoulder connecting the ampoule head with the ampoule body. The predetermined breaking point is typically identified by a coloured point at or coloured ring around the ampoule neck. In case the glass ampoule is a break ampoule, the ampoule is opened by hand in that a non-sterile swab is held with the index finger behind the ampoule neck to avoid cuts and the ampoule head is then broken away with the thumb as lever. After the glass ampoule has been opened the liquid pharmaceutical product is completely extracted from it and transferred to a syringe by means of a first hypodermic needle. After that the first hypodermic needle is disposed, as it might be contaminated, and possible air is removed from the syringe by moving air bubbles to its orifice through tapping on the syringe body. After the removal of possible air a sterile second hypodermic needle is placed on the syringe for administering of the pharmaceutical product to a patient through injection. The first hypodermic needle is not used for n the injection as it might have been contaminated through exposure to unsterile air. Instead a sterile second hypodermic needle is used for injection, which makes handling rather involved and time-consuming.
During opening of a break ampoule glass splinters may be formed that might enter the pharmaceutical product and that thus might be injected a patient during administration of the extracted pharmaceutical product.
If the pharmaceutical product is stored in a glass vial with a rubber stopper placed across and partly inside its neck, first a metal or plastic closure of the glass vial has to be removed. Then the rubber stopper has to be disinfected, with the disinfecting agent being typically applied for a predetermined amount of time. For extracting the pharmaceutical product a syringe with a hypodermic needle as be used, wherein unsterile ambient air is first sucked into the syringe through the hypodermic needle and than injected into the vial when piercing the hypodermic needle through the rubber stopper to create a positive pressure inside the vial. This has, however, the disadvantage that the pharmaceutical product might be contaminated by the unsterile air. Without the creation of the positive pressure inside the vial, the pharmaceutical product is hard to extract as the glass vial is not resilient.
To avoid the introduction of unsterile ambient air into the glass vial an adapter in form of a so-called mini-spike in conjunction with a hypodermic needle or a special hypodermic needle with integrated ventilation with filter may be used. A mini-spike is a plastic part with a hollow plastic spike by means of which the rubber stopper can be penetrated to extract the pharmaceutical product through the hypodermic needle placed in-side the hollow plastic spike. Excess pharmaceutical product that has been extracted is disposed of. Partly emptied glass vials are labelled with date and time as they may be used for 24 hours after opening. When piercing the rubber stopper with a hypodermic needle or a mini-spike for extraction of the pharmaceutical product, rubber particles are, however, potentially formed depending on the type and size of the used needle/spike that might contaminate the pharmaceutical product and that might then be injected a patient.